Digitally Trackable Pill Approved by US FDA For First Time

The United States Food and Drugs Administration has approved for the first time a pill with an ingestible sensor embedded inside it, which experts hope will improve medication compliance.

Abilify MyCite, a brand of aripiprazole tablets used for treating manic episodes and schitzophrenia, records that the tablet has been taken and ingested, through a patch worn by the patient that transmits this information to a smartphone. This information can also, with the explicit consent of the patient be sent to the doctor prescribing medication. This is done through a web-based portal.

The sensor, which is roughly a grain of sand in size, activates by coming into contact with stomach acid, and this information is transmitted to the patch worn on a patient’s body, which can be transmitted further to up to four other approved persons.

The intent for its use is for mental health medications, where there may be a concern about patients being unable to recall or otherwise confirm whether medications have been taken. However, the company behind Abilify MyCite, Otsuka Phamaceutical Co., Ltd, have noted that detection may be delayed or not occur so the sensor should not be used to track the ingestion during an emergency or “in real time”.

The company also notes in its prescribing information that there has not been any study that has shown the product to improve patient compliance.

There is also the more standard warning relating to using anti-psychotic drugs with people suffering from dementia and schitzophrenia. Neither Abilify nor Abilify MyCite are approved for treating dementia sufferers, as antipsychotics have a number of dangerous side effects when treating dementia-related psychosis, including an increased risk of strokes, the worsening of other dementia symptoms and an increased risk of death.

None of these disclaimers are surprising from a liability perspective; this is a very new technology and is probably still being tested for efficacy even if it has been approved by the FDA to treat some conditions.

In any case, it is a fascinating evolution of technology as it constantly develops to benefit patients and doctors who prescribe them, and it will be interesting to see how ingestible and injectable technology progresses forward to help an increasing number of health issues. It will be interesting to see how the medical, technological and ethical issues are handled going forward.